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FDA 510(k)

ERCHONIA EML LASER

K-Number: K041139 · 2004-09-30

ApplicantErchonia Medical, Inc.
Decision Date2004-09-30
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ERCHONIA EML LASER is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Medical, Inc.. It received FDA 510(k) clearance on 2004-09-30 under 510(k) number K041139. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERCHONIA EML LASER?

ERCHONIA EML LASER is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is Erchonia Medical, Inc.. The 510(k) number is K041139.

When did ERCHONIA EML LASER receive FDA 510(k) clearance?

ERCHONIA EML LASER received FDA 510(k) clearance on 2004-09-30, under 510(k) number K041139.

Who is the listed applicant for ERCHONIA EML LASER?

The FDA 510(k) record lists Erchonia Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERCHONIA EML LASER?

The FDA product code for ERCHONIA EML LASER is NHN.

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Other records listing Erchonia Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153164LunulaLaserK130996ERCHONIA EMERGEK130922ERCHONIA VERJU LASER SYSTEM WITH MASSAGERK130741ERCHONIA PL5000K120257MLS, ZERONA-ADK072206ERCHONIA EML LASER

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Related Devices (Code: NHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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